A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B (paradigm™7)

May 24, 2023 updated by: Novo Nordisk A/S

A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30159
        • Novo Nordisk Investigational Site
      • Mörfelden-Walldorf, Germany, 64546
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • Novo Nordisk Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male, aged 18-70 years (both inclusive) at the time of signing informed consent
  • Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
  • History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

  • Known history of factor IX inhibitors
  • Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
  • Immunocompromised (CD4+ T cells below or equal to 200/μL)
  • Known congenital or acquired coagulation disorders other than haemophilia B
  • Body mass index above 35 kg/m^²

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N9-GP
Drug: N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
Active Comparator: ALPROLIX®
Drug: ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
Time Frame: At 30 minutes
Calculated based on plasma FIX activity measured in blood
At 30 minutes
Terminal half-life (t½)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Clearance (CL)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Maximum activity (Cmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Activity at 30 minutes (C30min)
Time Frame: at 30 minutes
Calculated based on plasma FIX activity measured in blood
at 30 minutes
Activity at 168 hours (C168h)
Time Frame: At 168 hours
Calculated based on plasma FIX activity measured in blood
At 168 hours
Incremental recovery at maximum activity (IRCmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Time of maximum activity (tmax)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution during terminal phase (Vz)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Apparent volume of distribution at steady-state (Vss)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Mean residence time (MRT)
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Terminal elimination rate constant
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to infinity
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve from 0 to t last
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
From time 0 (dosing) up to 240 hours post-dose
Number of adverse events
Time Frame: From time 0 (dosing) up to 240 hours post-dose
Count and % of Adverse events
From time 0 (dosing) up to 240 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2017

Primary Completion (Actual)

December 8, 2017

Study Completion (Actual)

December 8, 2017

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7999-4260
  • 2016-001149-25 (EudraCT Number)
  • U1111-1180-7154 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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